(a) Specifications. Type A medicated articles: 4 percent (18.1 grams per pound (g/lb)), 8 percent (36.2 g/lb), and 20 percent (90.7 g/lb) fenbendazole.
(b) Approvals. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.275 of this chapter.
(d) Special considerations. See Sec. 500.25 of this chapter.
(e) Conditions of use--(1) Turkeys. ----------------------------------------------------------------------------------------------------------------
Amount fenbendazole in grams per Combination in grams
ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------14.5 (16 parts per million)...... .................... Growing turkeys: For Feed continuously 000061
the removal and as the sole ration
control of for 6 days. For
gastrointestinal growing turkeys
worms: roundworms, only.
adult and larvae
(Ascaridia
dissimilis); cecal
worms, adult and
larvae (Heterakis
gallinarum), an
important vector of
Histomonas meleagridis
(Blackhead).----------------------------------------------------------------------------------------------------------------
(2) Swine. ----------------------------------------------------------------------------------------------------------------
Amount fenbendazole in grams per Combination in grams
(i) 10 to 300 (to provide 9 .................... For the removal and Feed as sole ration 000061
milligrams per kilogram (mg/kg) control of: Adult
of body weight) given over a 3- stage lungworms
to 12-day period. (Metastrongylus apri
and M. pudendotectus);
adult and larvae (L3,
4 stages--liver, lung,
intestinal forms)
large roundworms
(Ascaris suum); adult
stage nodular worms
(Oesophagostomum
dentatum, O.
quadrispinulatum);
adult stage small
stomach worms
(Hyostrongylus
rubidus); adult and
larvae (L2, 3, 4
stages--intestinal
mucosal forms)
whipworms (Trichuris
suis); adult and
larvae kidney worms
(Stephanurus dentatus).(ii) 10 to 80 (to provide 9 mg/kg Lincomycin 20....... As in paragraph Feed as sole 000061
(i) of this ration. Do not
section; for increased feed to swine that
rate of gain in weigh more than
growing-finishing 250 pounds (lbs);
swine. lincomycin as
provided by 054771
in Sec.
510.600(c) of this
chapter.(iii) 10 to 80 (to provide 9 mg/ Lincomycin 40....... As in paragraph Feed as sole 000061
(i) of this ration. Do not
section; for control feed to swine that
of swine dysentery in weigh more than
animals on premises 250 lbs.;
with a history of lincomycin as
swine dysentery, but provided by 054771
where symptoms have in Sec.
not yet occurred. 510.600(c) of this
chapter.(iv) 10 to 80 (to provide 9 mg/kg Lincomycin 100...... As in paragraph Feed as sole 000061
(i) of this ration. Do not use
section; for the within 6 days of
treatment of swine slaughter. Do not
dysentery. feed to swine that
weigh more than
250 lbs.;
lincomycin as
provided by 054771
in Sec.
510.600(c) of this
chapter.(v) 10 to 80 (to provide 9 mg/kg Lincomycin 200...... As in paragraph Feed as sole 000061
(i) of this ration. Do not use
section; for reduction within 6 days of
in the severity of slaughter. Do not
swine mycoplasmal feed to swine that
pneumonia caused by weigh more than
Mycoplasma 250 pound (lb);
hyopneumoniae. lincomycin as
provided by 054771
in Sec.
510.600(c) of this
chapter.(vi) 10 to 300 (to provide 9 mg/ Bacitracin methylene Growing/finishing Feed as sole 054771
kg of body weight). disalicylate 10 to swine: As in paragraph ration. Under
(i) of this conditions of
section; for increased continued exposure
rate of weight gain to parasites,
and improved feed retreatment may be
efficiency. needed after 4 to
6 weeks.
Bacitracin
methylene
disalicylate as
provided by 054771
in Sec.
510.600(c) of this
chapter.(vii) 10 to 300 (to provide 9 mg/ Bacitracin methylene 1. Growing/finishing 1. Growing/ 054771
kg of body weight). disalicylate 250. swine: As in paragraph finishing swine:
(e)(2)(i) of this Feed as sole
(2)(i) of this Feed as sole
(i) of this Feed as sole
section; for control ration. Not for
of swine dysentery use in growing and
associated with finishing swine
Treponema that weigh more
hyodysenteriae on than 250 lbs.
premises with a Diagnosis of swine
history of swine dysentery should
dysentery, but where be confirmed by a
signs of disease have veterinarian when
not yet occurred; or results are not
following an approved satisfactory.
treatment of the Under conditions
disease condition. of continued
exposure to
parasites,
retreatment may be
needed after 4 to
6 weeks.
Bacitracin
methylene
disalicylate as
provided by 054771
in Sec.
510.600(c) of this
chapter.
.................... 2. Pregnant sows: As in 2. Pregnant sows: .........
paragraph (e)(2)(i) of Feed as sole
this section; for ration. Diagnosis
control of clostridial of clostridial
enteritis in suckling enteritis should
pigs caused by be confirmed by a
Clostridium veterinarian when
perfringens. results are not
satisfactory.
Under conditions
of continued
exposure to
parasites,
retreatment may be
needed after 4 to
6 weeks.
Bacitracin
methylene
disalicylate as
provided by 054771
in Sec.
510.600(c) of this
chapter.----------------------------------------------------------------------------------------------------------------
(3) Cattle. ------------------------------------------------------------------------
Amount Indications for
(i) 5 mg/kg Dairy and beef Feed as the sole 000061
body weight cattle: For ration or as a
(2.27 mg/lb) the removal top dress for one
and control day. Retreatment
of: Lungworms may be needed
(Dictyocaulus after 4 to 6
viviparus); weeks. Cattle
Stomach worms: must not be
barberpole slaughtered
worms within 13 days
(Haemonchus following last
contortus), treatment. For
brown stomach dairy cattle the
worms milk discard time
(Ostertagia is zero hours. A
ostertagi), withdrawal period
small stomach has not been
worms established for
(Trichostrongy this product in
lus axei); pre-ruminating
Intestinal calves. Do not
worms: use in calves to
hookworms be processed for
(Bunostomum veal..
phlebotomum),
thread-necked
intestinal
worms
(Nematodirus
helvetianus),
small
intestinal
worms
(Cooperia
oncophora and
C. punctata);
Bankrupt worms
(Trichostrongy
lus
colubriformis)
; and Nodular
worms
(Oesophagostom
um radiatum).(ii) [Reserved]------------------------------------------------------------------------
(iii) Free-choice feeds--(A) Amount. 5 mg/kg body weight (2.27 mg/lb), including the following formulations: ----------------------------------------------------------------------------------------------------------------
(1) Free-choice, dry Type C feed: .................................. ..................................
Salt (sodium chloride) 59.00 6-04-152
Monosodium phosphate 31.16 6-04-288
Dried cane molasses 3.12 4-04-695
Zinc sulfate 0.76 6-05-556
Copper sulfate 0.45 6-01-720
Fenbendazole 20% Type A article 5.51 n/a(2) Free-choice, dry Type C feed: .................................. ..................................
Salt (sodium chloride) 35.93 6-04-152
Dicalcium phosphate (18.5% P) 32.44 6-00-080
Calcium carbonate (38% Ca) 15.93 6-01-069
Magnesium oxide (56% Mg) 10.14 6-02-756
Zinc sulfate 1.47 6-05-556
Mineral oil 1.00 8-03-123
Dried cane molasses (46% sugars) 0.98 4-04-695
Potassium iodide 0.01 6-03-759
Fenbendazole 20% Type A article 2.10 n/a(3) Free-choice, liquid Type C feed:
Cane molasses\2\ 80.902 4-13-251
Water 9.36 n/a
Urea solution, 55% 7.05 5-05-707
Phosphoric acid 75% (feed grade) 2.00 6-03-707
Xantham gum 0.20 8-15-818
Trace minerals 0.20 n/a
Vitamin premix 0.01 n/a
Fenbendazole 20% Type A article 0.278 n/a----------------------------------------------------------------------------------------------------------------\1\The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those
used by the manufacturer for other free-choice cattle feeds. Formulation modifications require FDA approval
prior to marketing. Selenium is not approved for the free-choice formulations described in paragraph
(e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published
(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published
(iii) of this section. Free-choice cattle feeds containing selenium must comply with published
regulations (see 21 CFR 573.920).\2\The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the
brix value of the molasses to the industry standard of 79.5 brix.
(B) Indications for use. As in paragraph (e)(3)(i) of this section.
(C) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3- to 6-day period. Retreatment may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 13 days following last treatment. For dairy cattle the milk discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
(4) Horses. ----------------------------------------------------------------------------------------------------------------
(i) 4,540............................. 5 mg/kg body weight (2.27 mg/ Feed at the rate of 0. 1lb of 000061
lb) for the control of large feed per 100 lb of body
strongyles (Strongylus weight to provide 2.27 mg
edentatus, S. equinus, S. fenbendazole/lb of body
vulgaris, Triodontophorus weight in a 1-day treatment
spp.), small strongyles or 0.2 lb of feed per 100 lb
(Cyathostomum spp., of body weight to provide
Cylicocyclus spp., 4.54 mg fenbendazole/lb of
Cylicostephanus spp.), and body weight in a 1-day
pinworms (Oxyuris equi); 10 treatment. All horses must
mg/kg body weight (4.54 mg/ be eating normally to ensure
lb) for the control of that each animal consumes an
ascarids (Parascaris adequate amount of the
equorum).. medicated feed. Regular
deworming at intervals of 6
to 8 weeks may be required
due to the possibility of
reinfection. Do not use in
horses intended for human
consumption..(ii) [Reserved]....................... .............................. ............................. .........----------------------------------------------------------------------------------------------------------------
(5) Zoo and wildlife animals. ----------------------------------------------------------------------------------------------------------------
(i) Feral swine (Sus scrofa)..... 3 mg/kg/day for 3 For the removal and Use as complete 000061
days.. control of kidney worm feed. Prior
(Stephanurus withdrawal of feed
dentatus), roundworm or water is not
(Ascaris suum), necessary.
nodular worm Retreatment may be
(Oesophagostomum required in 6
dentatum). weeks. Do not use
14 days before or
during the hunting
season.(ii) Ruminants (subfamily 2.5 mg/kg/day for 3 For the removal and Use as complete 000061
Antilopinae, Hippotraginae, days.. control of small feed. Prior
Caprinae). stomach worm withdrawal of feed
(Trichostrongylus or water is not
spp.), thread necked necessary.
intestinal worm Retreatment may be
(Nematodirus spp.), required in 6
barberpole worm weeks. Do not use
(Haemonchus spp.), 14 days before or
whipworm (Trichuris during the hunting
spp.). season.
(iii) Rocky mountain bighorn 10 mg/kg/day for 3 For the removal and Use as complete 000061
sheep (Ovis c. canadensis). days.. control of feed. Prior
Protostrongylus spp. withdrawal of feed
or water is not
necessary.
Retreatment may be
required in 6
weeks. Do not use
14 days before or
during the hunting
season.---------------------------------------------------------------------------------------------------------------- [66 FR 58935, Nov. 26, 2001, as amended at 68 FR 34534, June 10, 2003; 72 FR 66046, Nov. 27, 2007; 73 FR 58873, Oct. 8, 2008; 74 FR 61517, Nov. 25, 2009; 79 FR 13545, Mar. 11, 2014]